22-gauge Fine-Needle Aspiration System Versus 22-gauge ProCore Needle for the Evaluation of Pancreatic Mass Lesions at Endoscopic Ultrasound

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shyam Varadarajulu, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01394159
First received: July 12, 2011
Last updated: December 26, 2011
Last verified: December 2011
  Purpose

The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.


Condition Intervention
Pancreatic Neoplasm
Procedure: Procore Biopsy
Procedure: FNA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Compare the median number of passes required to establish a diagnosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ProCore Biopsy
Acquire biopsy with procore needle
Procedure: Procore Biopsy
Acquire tissue with procore biopsy needle
Other Name: Acquire tissue with ProCore needle
Active Comparator: FNA Procedure: FNA
Acquire tissue with FNA needle

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-All patients with solid pancreatic mass lesions

Exclusion Criteria:

  • Coaguloapthy,
  • minors,
  • prgenant patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394159

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
Shyam Varadarajulu
Investigators
Principal Investigator: Shyam Varadarajulu, MD University of Alabama at Birmingham
  More Information

No publications provided by University of Alabama at Birmingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shyam Varadarajulu, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01394159     History of Changes
Other Study ID Numbers: F110506010
Study First Received: July 12, 2011
Last Updated: December 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
passes required to establish diagnosis

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 01, 2014